Agency Information Collection Activities: Submission for OMB Review; Comment Request, 21254-21255 [2024-06439]
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21254
Federal Register / Vol. 89, No. 60 / Wednesday, March 27, 2024 / Notices
Board of Governors of the Federal Reserve
System.
Ann Misback,
Secretary of the Board.
[FR Doc. 2024–06537 Filed 3–26–24; 8:45 am]
BILLING CODE P
Board of Governors of the Federal Reserve
System.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
FEDERAL RESERVE SYSTEM
khammond on DSKJM1Z7X2PROD with NOTICES
Change in Bank Control Notices;
Acquisitions of Shares of a Bank or
Bank Holding Company
[FR Doc. 2024–06496 Filed 3–26–24; 8:45 am]
BILLING CODE P
The notificants listed below have
applied under the Change in Bank
Control Act (Act) (12 U.S.C. 1817(j)) and
§ 225.41 of the Board’s Regulation Y (12
CFR 225.41) to acquire shares of a bank
or bank holding company. The factors
that are considered in acting on the
applications are set forth in paragraph 7
of the Act (12 U.S.C. 1817(j)(7)).
The public portions of the
applications listed below, as well as
other related filings required by the
Board, if any, are available for
immediate inspection at the Federal
Reserve Bank(s) indicated below and at
the offices of the Board of Governors.
This information may also be obtained
on an expedited basis, upon request, by
contacting the appropriate Federal
Reserve Bank and from the Board’s
Freedom of Information Office at
https://www.federalreserve.gov/foia/
request.htm. Interested persons may
express their views in writing on the
standards enumerated in paragraph 7 of
the Act.
Comments regarding each of these
applications must be received at the
Reserve Bank indicated or the offices of
the Board of Governors, Ann E.
Misback, Secretary of the Board, 20th
Street and Constitution Avenue NW,
Washington, DC 20551–0001, not later
than April 11, 2024.
A. Federal Reserve Bank of Kansas
City (Jeffrey Imgarten, Assistant Vice
President) 1 Memorial Drive, Kansas
City, Missouri, 64198–0001. Comments
can also be sent electronically to
KCApplicationComments@kc.frb.org:
1. Too Many Investors, LLC and
Dallen Jon (D.J.) Hogstad, both of
Comanche, Oklahoma; to become
members of the Hogstad Control Group,
a group acting in concert, to retain
voting shares of Commerce Financial
Company, and thereby indirectly retain
voting shares of Bank of Commerce,
both of Duncan, Oklahoma.
2. PBI Trust 35, Thomas S. Dinsdale,
as trustee, both of Grand Island,
Nebraska; to become members of the
Dinsdale Family group, a group acting
in concert, to retain voting shares of
Pinnacle Bancorp, Inc., Omaha,
VerDate Sep<11>2014
17:03 Mar 26, 2024
Jkt 262001
Nebraska, and thereby indirectly retain
voting shares of Pinnacle Bank, Lincoln,
Nebraska; Pinnacle Bank, Fort Worth,
Texas; Pinnacle Bank—Wyoming, Cody,
Wyoming; and Bank of Colorado, Fort
Collins, Colorado.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10883 and CMS–
10558]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by April 26, 2024.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
SUMMARY:
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information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: ADA Dental
Claim Form; Use: The ADA Dental
Claim form and corresponding HIPAAcompliant electronic transaction, known
as the 837D, are used widely in the US
dental industry to submit claims for
health or dental insurance
reimbursement.
Medicare has traditionally accepted
the Professional (CMS–1500/837P
transaction) and Institutional (UB04/
837I transaction) claims to provide
payment for Medicare-covered services.
The Centers for Medicare & Medicaid
Services (CMS) now plans to allow
providers to submit Medicare-covered
dental services on the dental claim
form, a similar information collection as
the already-approved professional and
institutional claim forms.
CMS issued policy clarifications as
part of its annual Medicare Physician
Fee Schedule (MPFS) Rule that further
E:\FR\FM\27MRN1.SGM
27MRN1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 60 / Wednesday, March 27, 2024 / Notices
define when dental services are
inextricably linked to a covered medical
service. Additional clarifications were
included in the CY2024 MPFS final
rule. CMS further established a process
by which the agency will consider
clinical evidence for future policy
clarification consideration. CMS
anticipates that these regulatory policy
clarifications will result in more dental
provider participation in the Medicare
program. As a result, the Agency’s
General Counsel has advised that CMS
should begin to accept dental claim
formats to remain in compliance with
the Health Insurance Portability and
Accountability Act (HIPAA) (Pub. L.
104–191). Therefore, CMS through its
Part B Medicare Administrative
Contractors (MACs) will begin accepting
and processing claims submitted by
dental providers on the ADA Dental
Claim form and HIPAA-standard
electronic format equivalent (837D).
Form Number: CMS–10883; Frequency:
Occasionally; Affected Public: Private
Sector, Business or other for-profits;
Number of Respondents: 50,000; Total
Annual Responses: 50,000; Total
Annual Hours: 12,500. (For policy
questions regarding this collection
contact Charlene Parks at 410–786–
8684).
2. Type of Information Collection
Request: Extension of currently
approved Information Collection; Title
of Information Collection: Machine
Readable Data for Provider Network and
Prescription Formulary Content for FFM
QHPs; Use: Under 45 CFR
156.122(d)(1)(2), 156.230(b), and
156.230(c), as finalized in the rule, the
Patient Protection and Affordable Care
Act; HHS Notice of Benefit and Payment
Parameters for 2018 (CMS–9934–F),
established standards for qualified
health plan (QHP) issuers for the
submission of provider and formulary
data in a machine-readable format to the
Department of Health and Human
Services (HHS) and for posting the data
on issuer websites. These standards
provide greater transparency for
consumers, including by allowing
software developers to access formulary
and provider data to create innovative
and informative tools. On September 30,
2015, the Office of Management and
Budget (OMB) granted approval to the
data collection Information Collection
for Machine Readable Data for Provider
Network and Prescription Formulary
Content for FFE QHPs under OMB
control number 0938–1284. OMB
approval was granted again on
November 3, 2017, and March 22, 2021.
The Centers for Medicare and Medicaid
Services (CMS) is continuing that
VerDate Sep<11>2014
17:03 Mar 26, 2024
Jkt 262001
information collection request (ICR) in
connection with these machine-readable
standards. This ICR serves as a formal
request for the renewal of the data
collection clearance. The burden
estimate for the ICR included in this
package reflects the time and effort for
QHP and SADP issuers to update and
publish the appropriate data and submit
it to CMS. No comments were received
in response to the 60-day Federal
Register notice. Form Number: CMS–
10558 (OMB control number: 0938–
1284); Frequency: Annually; Affected
Public: Private Sector, State, Business,
and Not-for-Profits; Number of
Respondents: 434; Number of
Responses: 434; Total Annual Hours:
39,126. (For questions regarding this
collection, contact Ana Alza at (667)
290–8569, ext. 70008569).
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–06439 Filed 3–26–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2002–D–0176 (Formerly
Docket No. 2002D–0350)]
Handling and Retention of
Bioavailability and Bioequivalence
Testing Samples; Guidance for
Industry (Part Draft, Part Final);
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled
‘‘Handling and Retention of BA and BE
Testing Samples.’’ This guidance is
intended to provide recommendations
for applicants of new drug applications
(NDAs) and abbreviated new drug
applications (ANDAs), including
supplemental applications, and contract
research organizations (CROs), regarding
the procedures for handling reserve
samples from relevant bioavailability
(BA) and bioequivalence (BE) studies,
and recommendations regarding
responsibilities of each party involved
in the study pertaining to reserve
samples. Additionally, this guidance
describes the conditions under which
the Agency generally does not intend to
take enforcement action against an
applicant or CRO that retains less than
SUMMARY:
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21255
the quantity of reserve samples
specified in the regulation.
DATES: Submit either electronic or
written comments on the draft portion
of this guidance by May 28, 2024 to
ensure that the Agency considers your
comment on this draft guidance before
it begins work on the final version of the
guidance. Comments on the final
portion of this guidance may be
submitted at any time for Agency
consideration.
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2002–D–0176 (formerly Docket No.
2002D–0350) for ‘‘Handling and
Retention of BA and BE Testing
Samples.’’ Received comments will be
E:\FR\FM\27MRN1.SGM
27MRN1
Agencies
[Federal Register Volume 89, Number 60 (Wednesday, March 27, 2024)]
[Notices]
[Pages 21254-21255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06439]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10883 and CMS-10558]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (PRA), federal agencies are required to publish notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension or reinstatement of an
existing collection of information, and to allow a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate or any other aspect of this
collection of information, including the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected, and the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
DATES: Comments on the collection(s) of information must be received by
the OMB desk officer by April 26, 2024.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, please access
the CMS PRA website by copying and pasting the following web address
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. The term ``collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires
federal agencies to publish a 30-day notice in the Federal Register
concerning each proposed collection of information, including each
proposed extension or reinstatement of an existing collection of
information, before submitting the collection to OMB for approval. To
comply with this requirement, CMS is publishing this notice that
summarizes the following proposed collection(s) of information for
public comment:
1. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection: ADA
Dental Claim Form; Use: The ADA Dental Claim form and corresponding
HIPAA-compliant electronic transaction, known as the 837D, are used
widely in the US dental industry to submit claims for health or dental
insurance reimbursement.
Medicare has traditionally accepted the Professional (CMS-1500/837P
transaction) and Institutional (UB04/837I transaction) claims to
provide payment for Medicare-covered services. The Centers for Medicare
& Medicaid Services (CMS) now plans to allow providers to submit
Medicare-covered dental services on the dental claim form, a similar
information collection as the already-approved professional and
institutional claim forms.
CMS issued policy clarifications as part of its annual Medicare
Physician Fee Schedule (MPFS) Rule that further
[[Page 21255]]
define when dental services are inextricably linked to a covered
medical service. Additional clarifications were included in the CY2024
MPFS final rule. CMS further established a process by which the agency
will consider clinical evidence for future policy clarification
consideration. CMS anticipates that these regulatory policy
clarifications will result in more dental provider participation in the
Medicare program. As a result, the Agency's General Counsel has advised
that CMS should begin to accept dental claim formats to remain in
compliance with the Health Insurance Portability and Accountability Act
(HIPAA) (Pub. L. 104-191). Therefore, CMS through its Part B Medicare
Administrative Contractors (MACs) will begin accepting and processing
claims submitted by dental providers on the ADA Dental Claim form and
HIPAA-standard electronic format equivalent (837D). Form Number: CMS-
10883; Frequency: Occasionally; Affected Public: Private Sector,
Business or other for-profits; Number of Respondents: 50,000; Total
Annual Responses: 50,000; Total Annual Hours: 12,500. (For policy
questions regarding this collection contact Charlene Parks at 410-786-
8684).
2. Type of Information Collection Request: Extension of currently
approved Information Collection; Title of Information Collection:
Machine Readable Data for Provider Network and Prescription Formulary
Content for FFM QHPs; Use: Under 45 CFR 156.122(d)(1)(2), 156.230(b),
and 156.230(c), as finalized in the rule, the Patient Protection and
Affordable Care Act; HHS Notice of Benefit and Payment Parameters for
2018 (CMS-9934-F), established standards for qualified health plan
(QHP) issuers for the submission of provider and formulary data in a
machine-readable format to the Department of Health and Human Services
(HHS) and for posting the data on issuer websites. These standards
provide greater transparency for consumers, including by allowing
software developers to access formulary and provider data to create
innovative and informative tools. On September 30, 2015, the Office of
Management and Budget (OMB) granted approval to the data collection
Information Collection for Machine Readable Data for Provider Network
and Prescription Formulary Content for FFE QHPs under OMB control
number 0938-1284. OMB approval was granted again on November 3, 2017,
and March 22, 2021. The Centers for Medicare and Medicaid Services
(CMS) is continuing that information collection request (ICR) in
connection with these machine-readable standards. This ICR serves as a
formal request for the renewal of the data collection clearance. The
burden estimate for the ICR included in this package reflects the time
and effort for QHP and SADP issuers to update and publish the
appropriate data and submit it to CMS. No comments were received in
response to the 60-day Federal Register notice. Form Number: CMS-10558
(OMB control number: 0938-1284); Frequency: Annually; Affected Public:
Private Sector, State, Business, and Not-for-Profits; Number of
Respondents: 434; Number of Responses: 434; Total Annual Hours: 39,126.
(For questions regarding this collection, contact Ana Alza at (667)
290-8569, ext. 70008569).
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-06439 Filed 3-26-24; 8:45 am]
BILLING CODE 4120-01-P